This presentation includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control
that could cause actual results to differ materially from the results discussed
in the forward-looking statements. Forward-looking statements include
statements regarding our short-term objectives and opportunities, financial
expectations for the full year and financial preparedness as of year end, as
well as statements concerning our plans, objectives, goals, future events,
performance and/or other information that is not historical information. All
such forward-looking statements are expressly qualified by these cautionary
statements and any other cautionary statements which may accompany the
forward-looking statements. We undertake no obligation to publicly update
or revise forward-looking statements to reflect subsequent events or
circumstances after the date made, except as required by law.
BAVARIAN NORDIC
CANCER IMMUNOTHERAPIES AND VACCINES FOR INFECTIOUS DISEASES
FACTS
BAVARIAN NORDIC IN BRIEF
• Vertically integrated multinational biotech company
• Revenue-generating
• Leader in vector-based active immunotherapy
• First product approved in 2013
• Three Phase 3 programs: Prostate cancer, Ebola and smallpox
• Commercial scale cGMP manufacturing facility
• Long-term R&D and delivery contracts with the US government
Founded 1994, IPO 1998
Listed on Nasdaq Copenhagen: BAVA 28m shares outstanding
MULTIPLE LAYERS OF VALUE
Validated Platform Technology (NIH, BARDA, BMS, Janssen)
1 approved product 7 active programs
3 Phase 3 Products
Multiple near-term milestones
$1.2B in US government contracts
$950M in revenues over past 10 years $975M BMS deal - PROSTVAC
$358M Janssen deals – Ebola and HPV
Expertise in T-Cell Stimulation & Antibody Response
Strong Revenue Base to Re-Invest in Clinical Pipeline
2 focus areas
Infectious Disease & Oncology
Broad Pipeline & Late-Stage Candidates
RESEARCH AND PRODUCTION AT THE FOREFRONT.
Headquarters &
Large scale manufacturing Kvistgård, Denmark
• 9,000sqm multiproduct manufacturing
facility, QA/QC and administration
• Approx. 270 employees
Martinsried Germany
• R&D facilities located in the “Biotech Region of Munich” - one of the leading biotech regions in Europe • Approx. 110 employees Redwood City, CA USA • Clinical development situated close to recognized universities that are leaders within cancer immunology.
Commercial Production Facility
• Inspected by the EMA and the FDA
• 28M doses of IMVAMUNE delivered to US
national stockpile
• Over 2M doses of MVA-BN Filo (Ebola)
delivered to Janssen
Poxvirus Manufacturing Expertise
• Commercial partnerships in place with
Janssen & BMS
• All manufacturing performed by BN
• Company has developed IP and extensive
know-how in the production of poxvirus based vaccines
COMMERCIAL MANUFACTURING CAPABILITIES
Multi-Product Facility
• Highly scalable, fully integrated, reduces
dependency on sub-contractors
• Fill/Finish established to support commercial
launch of PROSTVAC
CLINICAL PIPELINE
PRODUCT CANDIDATE INDICATION COMMERCIAL RIGHTS PRIMER / BOOSTER PRECLINICAL PHASE 1 PHASE 2 PHASE 3 APPROVED STATUS / EXPECTED MILESTONES
Infectious Disease
IMVAMUNE / IMVANEX
(LIQUID FROZEN)
Smallpox MVA-BN MVA-BN Approved in Canada and the
European Union
Smallpox MVA-BN MVA-BN Complete enrollment in 2017
IMVAMUNE
(FREEZE DRIED) Smallpox
MVA-BN
MVA-BN Manufacturing validation
MVA-BN Filo Ebola / Marburg AdVac(a)
MVA-BN Data from multiple trials in 2016
MVA-BN RSV RSV MVA-BN MVA-BN Phase 1 trial data in 1H16
HPV Vaccine HPV AdVac(a)
MVA-BN Deal signed in December 2015
Cancer Immunotherapy
PROSTVAC mCRPC Vaccinia Fowlpox Three interim analyses likely starting in 1Q16
with top-line data in 2017
Localized Prostate Cancer Vaccinia Fowlpox NCI enrolling Phase 2 trial Localized Prostate Cancer
(neoadjuvant)
Vaccinia
Fowlpox NCI Phase 2 trial data in 2016
Non-Metastatic Castration Sensitive Prostate Cancer
Vaccinia
Fowlpox NCI enrolling Phase 2 trial
mCRPC Vaccinia Fowlpox NCI enrolling Phase 2 trial
Metastatic Castration
Sensitive Prostate Cancer Vaccinia Fowlpox NCI enrolling Phase 2 trial Non-Metastatic Prostate
Cancer
Vaccinia
Fowlpox NCI Phase 2 trial data in 1H16
Prostate Cancer Vaccinia Fowlpox NCI Phase 1 trial enrollment complete
CV 301 Bladder Cancer Vaccinia
(c)
Fowlpox NCI enrolling Phase 2 NCI trial
MVA-BN Brachyury Solid Tumors MVA-BN
MVA-BN(d) Phase 1 data reported in 4Q15
(b) (b) (b) (b) (b) (b)
Approved in Canada and the European Union Phase 3 in US (non-inferiority)
Phase 2 complete
Fully enrolled
PROSPECT fully enrolled
+ XTANDI (enzalutamide)
+ XTANDI (enzalutamide) ipilimumab
+ ADT and docetaxel
(b) (b)
2015/2016 HIGHLIGHTS
• Global commercialization agreement for PROSTVAC with Bristol-Myers Squibb –
potential value of $975M including option and milestone payments and $60M upfront.
• Product license agreement with Janssen (Johnson & Johnson) for MVA-BN HPV - $9M
upfront, & potential of 162M in development & sales milestones
PARTNERSHIPS
$181M vaccine supply and R&D contracts from the US government
• $15M expansion of NIH contract for Filovirus vaccine development (June 2015)
• $133M IMVAMUNE bulk order received by BARDA (July 2015)
• $33M R&D MVA-BN Filo BARDA contract (subcontractor to Janssen award)
2015/2016 HIGHLIGHTS
CONTINUED
Multiple clinical studies initiated
• MVA-BN RSV Phase 1 in U.S.
• PROSTVAC Phase 2 active surveillance study in men with localized prostate cancer
• PROSTVAC + docetaxel combination Phase 2 study in metastatic prostate cancer
(2016)
• PROSTVAC Phase 2 study in non-metastatic castration sensitive prostate cancer (2016)
• PROSTVAC first interim analysis has occurred; study continues as planned (2016)
• Ebola prime boost phase 3 study
• Reported pivotal Phase 2 & 3 IMVAMUNE data
• Reported long-term survival Phase 1 data of combination of PROSTVAC and
ipilimumab
• Reported Phase 1 Brachyury data in 38 patients with advanced cancer
• Reported Phase 1 Ebola data
SUCCESSFUL PARTNERSHIP WITH THE U.S. GOVERNMENT
CONTRACTS AWARDED TO-DATE EXCEED US$ 1.2 BN
Developing, producing, supplying liquid-frozen IMVAMUNE®
Developing freeze-dried vaccine Expanding MVA-BN® platform
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 RFP-1 IMVAMUNE Smallpox Vaccine US$ 14m NIH RFP-3 IMVAMUNE Smallpox Vaccine US$ 500m BARDA RFP-2 IMVAMUNE Smallpox Vaccine US$ 100m NIH RFP-2 Expansion IMVAMUNE Smallpox Vaccine US$ 16m NIH RFP-3 Expansions IMVAMUNE Smallpox Vaccine US$ 49m BARDA RFP Freeze Dried IMVAMUNE Smallpox Vaccine US$ 40m BARDA RFP Freeze Dried Expansion US$ 55m BARDA MVA-BN Marburg US$ 18m NIH MVA-BN Foot-and-mouth disease US$ 1m DHS Delivery contract IMVAMUNE Smallpox Vaccine US$ 228m BARDA 2013 2014 MVA-BN Burkholderia US$ 500k DOD DTRA Bulk Order IMVAMUNE Smallpox Vaccine US$ 133m BARDA 2015 MVA-BN Marburg Expansion US$ 15m NIH MVA-BN Ebola Subcontract US$ 33m BARDA
Recent events continue to drive confidence
• Phase 2 complete
• Manufacturing activities ongoing to support an EUA
• RFP expected to be issued by USG
• USD 133 million bulk order from BARDA (July 2015)
• Initial order allows for immediate transition to FD once RFP occurs and FD pricing can be established
Potential
• First wave of replenishment could replace
20 million expiring doses in stockpile
• Long term stated goal of US Government calls for
non-replicating vaccine for 66 million US citizens (~132 million doses)
IMVAMUNE
PSA
CEA, MUC-1 HER-2 Brachyury
Tumor antigens with epitopes enhanced for HLA binding Prostate, lung, head & neck, bladder, colorectal, breast, ovarian and renal cancers
TRICOM
(TRIad of COstimulatory Molecules)
Enhance T-Cell activation in synergistic manner
Strengthen the anticancer immune response
TRICOM
TAA LFA-3 ICAM-1 B7.1 Heterologous prime/boost regimen Vaccinia or MVA + Fowlpox Subcutaneous administration
V
F
Safe and well tolerated (11 clinical trials)
Injection site reactions and flu-like symptoms
PROSTVAC
PROSTVAC INDUCES AN ANTIGEN CASCADE AGAINST
PROSTATE CANCER CELLS
Test Result Comment
PSA-Specific Immune response 56.7% (59/104) 28 days after last vaccine
Median fold increase in
PSA-specific immune response 5X
PSA response 30 / 106 cells
flu response 33 / 106 cells
Antigen Cascade 67.9% (19/28)
Anti-PSA Ab 0.57% (2/349)
PROSTVAC PHASE 3 STUDY
18,4% 17,7% 38,2% 25,7%Randomization by region (N=1,297)
USA, Canada Belgium, Denmark, France, Germany,Iceland, Netherlands, Spain, United Kingdom
Australia, Estonia, Israel, Poland, Russia North America Urology (n=229) North America Oncology (n=239) Rest of World (n=333) Western Europe (n=497)
Injections
1) Subjects who have completed study treatment phase or have completed 7th
dosing visit. N=1,279
• Average was 6.1 injections1
• Randomized Phase 2 trial (n=122) had
average of 5.4 injections2
• An increased number of injections is expected to improve the clinical outcome for patients receiving the active drug.
2) Kantoff et al., Journal of Clinical Oncology, January 2010
PROSTVAC + GM-CSF PROSTVAC Placebo
3 study arms
PROSPECT
A Randomized, Double-blind, Global Phase 3 Efficacy Trial of PROSTVAC in MetastaticENTRY CRITERIA
Randomized Phase 2 PROSPECT Phase 3
ECOG < 2
No visceral metastases
Asymptomatic (no cancer-related pain requiring narcotics) No prior chemotherapy
• Gleason score < 7 (from original biopsy)
• Removed Gleason score exclusion
− Gleason grade not associated with treatment effect
in other phase 3 mCRPC trials (sip-T, ipilimumab)
• No alkaline phosphatase exclusion • Changed to exclude patients with alk phos > 2 times ULN
− Excludes more advanced metastatic disease
• No LDH exclusion • Changed to exclude patients with LDH > 2 times ULN
− Excludes more advanced metastatic disease
• No PSA doubling time (PSA-DT) exclusion • Added exclusion for patients with PSA-DT < 1 month
− Excludes patients with fast growing tumors
• Minimum PSA value for determination of CRPC = 5
ng/mL (PCWG1)
• Minimum PSA value for determination of CRPC lowered to 2 ng/mL (PCWG2)
First interim analysis of the PROSPECT Phase 3 study has occurred
• A recent review by the Data Monitoring Committee informed BN to “Continue the
trial without modification”
• Interim 1 was an analysis of each of the active PROSTVAC arms (with or without
GM-CSF) versus placebo, thus requiring at least 214 events per comparison (equals 40% of the 534 events required for final overall survival analysis)
• 2 additional interim analyses remain
• Final overall survival data anticipated in 2017
PROSTVAC: INTERIM ANALYSES UNDERWAY
Interim Analysis #1 214 events 40%
Interim Analysis #2 321 events 60%
Interim Analysis #3 427 events 80%
Final Overall Survival Analysis 534 events 100%
DEMONSTRATED POTENTIAL AS A COMBINATION
THERAPY WITH BMS’ IPILIMUMAB
0 12 24 36 48 60 Su rv iv al (% of p at ie nt s) 0 20 40 60 80 100 16.6 months 25.1 months Months 0 24 48 72 Su rv iv al (% of pa tie n ts) 0 20 40 60 80 100 PROSTVAC + Ipi (all Ipi dose cohorts)
31.6 months Months Patients in 10mg/kg dose cohort (N=15) reported 37.2 months median overall survival ~20% of 10mg/kg patients remain alive at 80 months
PROSTVAC Phase 2 Trial PROSTVAC + Ipilimumab Phase 1 Trial
Further investigation of PROSTVAC in collaboration with BMS
• Two new investigator-sponsored trials planned for initiation
PROSTVAC COMBINATION TRIALS
TWO NEW TRIALS PLANNED FOR INITIATION
PROSTVAC ipilimumab PROSTVAC + ipi
Open label combination trial in localized prostate cancer using PROSTVAC and ipilimumab as neoadjuvant therapy. Phase 2 (n=75) Sponsor: UCSF Clinicaltrials.gov NCT02506114 Randomization 1:1:1
PROSTVAC + ipi + nivo PROSTVAC + ipi
Open label combination trial in prostate cancer using
PROSTVAC, ipilimumab and
nivolumab as neoadjuvant therapy
Phase 2
(n=28)
STUDIES SPAN PROSTATE CANCER DISEASE LANDSCAPE
docetaxel ADT
surgery
Hormone dependent Castration resistant
No pain Pain Nonmetastatic Metastatic Phase 3 (BN) enza combo (NCI) flutamide combo (NCI)
abi, enza, Ra-223, cabazitaxel sip-T, enza, abi, Ra-223 Active surveillance (NCI) Neoadjuvant (NCI) enza combo (NCI)
†
death Tumor volume• Mechanism of action (MOA)
• Immune infiltration to tumor, immune response, biomarkers, and PSA kinetics
• Use in combination
• With currently approved therapies for mCRPC, and with checkpoint inhibitors
• Use in earlier prostate cancer to support future label expansion
mono (NCI)
ADT + docetaxel combo (NCI)
Elements
Value
Upfront payment
$60M
License
$80M
Phase 3 data
$50M
Data-driven milestones
$180M*
Regulatory milestones
$110M
Sales milestones
$495M
Tiered royalties on future sales
High teens up to mid-twenties
COMMERCIAL LICENSE WITH BMS
New and improved vaccine construct based on MVA-BN
CV-301
CV-301 FOR MULTIPLE CANCERS
MUC-1
CEA Lung, Breast, Colorectal, Ovarian,
Gastric, Bladder, Liver and Renal cancer MVA-BN Fowlpox TRICOM
+
=
CV-301 development strategy
• Combination treatment with checkpoint inhibitor(s)
• Short-term clinical outcomes possible (Overall Response Rate, Progression-Free Survival)
• Partnering opportunity based on proof-of-concept data
COMPLETE TUMOR REGRESSION FROM POXVIRUS-BASED
IMMUNOTHERAPY COMBINED WITH PD-1 & LAG-3
BLOCKADE
Control anti-PD1 + 14/20 anti-LAG3 MVA-BN-HER2 2/20 MVA-BN-HER2 20/20 + anti-PD1 + anti-LAG3CT26-HER2 solid tumor model:
MVA-BN-HER2 immunotherapy (s.c.) and/or PD1 + anti-LAG3 antibody (i.p.)
Q2wks x2 (d1 and 15) C o n t r o l T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 M V A -B N - H E R 2 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 M V A -B N - H E R 2 + a n t i- P D -1 + a n ti-L A G -3 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0 a n t i- P D - 1 + a n ti-L A G -3 T u m o r V o lu m e (m m 3 ) 0 1 0 2 0 3 0 4 0 0 1 0 0 2 0 0 3 0 0 4 0 0 5 0 0
Durable Response
After Mice Were
Re-Challenged
CV-301 PRODUCT DEVELOPMENT STRATEGY
Preliminary evidence of efficacy generated in multiple clinical studies. Safety data with over 300 subjects treated.
Leverage Existing
Clinical Data
CV-301 in Combination with Immune
Checkpoint Inhibitors
NCSLC
Bladder
Colorectal
BN sponsored Exploring combinations with PD-1/PD-L1 in company collaborations or with NCIJanssen Deal
Clinical Status
Additional Commercial
Targets
• $45M licensing agreement
grants Janssen full
commercialization rights
• BN eligible to receive
royalties outside of Africa
• Additional supply
agreement of $99M
• Equity investment of $43M
(~5% of BN)
• Janssen presented
preliminary Phase 1 data in May 2015
• Multicenter Phase 2
clinical trial initiated in July 2015 in the United Kingdom and France
• Phase 2 trial (n=1,200)
and a Phase 3 trial have been initiated in Africa
• Data expected in 2016
• Entered into subsequent
$171M agreement with Janssen for a therapeutic HPV vaccine in December 2015
• Two additional
undisclosed targets also being explored
• MVA-BN is a promising
booster to existing Janssen technology (AdVac from Crucell)
MVA-BN FILO: OUR PHASE 3 EBOLA VACCINE PARTNERED
WITH JANSSEN
29
FIRST IN HUMAN DATA FOR THE BAVARIAN
NORDIC/JANSSEN EBOLA PRIME-BOOST VACCINE
• 72 healthy volunteers
randomized into four groups receiving prime-boost vaccine regimen or placebo at intervals of 28 or 56 days
• An open-label arm with 15
healthy volunteers is also investigating a shorter prime-boost interval of 14 days for Ad26.ZEBOV
prime and MVA-BN Filo boost
Phase 2 & 3 Clinical Trials Ongoing in the US, EU and Africa
AdVac + MVA-BN Provides Durable Response
0 50 100 150 200 10 100 1000 10000 100000 Antibodies (ELISA) Days E L I S A U n i t s / m l 0 50 100 150 200 0.01 0.1 1 10 CD8+ T cells (ICS) Days T o t a l c y t o k i n e r e s p o n s e ( % o f s u b s e t ) 0 50 100 150 200 10 100 1000 10000 100000 Antibodies (ELISA) Days E L IS A U n it s/ m l 0 50 100 150 200 0.01 0.1 1 10 CD8+ T cells (ICS) Days T ot al cy to ki n e re sp o n se (% o f su b se t) Ad26/MVA 0, 28 Ad26/MVA 0, 56
•
Subsequent to the Ebola collaboration, BN and Janssen
agreed to collaborate on three additional infectious
disease targets
•
The first indication now licensed with Janssen
•
A therapeutic vaccine for individuals with an active human papillomavirus
(HPV) infection
• Novel approach for early treatment and interception of HPV-induced cancers
• High-risk HPV types cause approximately 5 percent of all cancers worldwide
EXPANSION OF JANSSEN COLLABORATION: HPV VACCINE
$171M AGREEMENT SIGNED IN DECEMBER 2015
MVA-BN HPV deal structure
• Total potential agreement value $171 million including $9 million upfront plus milestone payments and single-digit royalties on sales
• Janssen expected to initially focus on infected women at risk for cervical cancer, and then head and neck cancers
Development strategy
Elderly +Adults at risk
Children >5yrs Phase 1- Enrolled Phase 1/2
2015
Phase 2- Initiate H22016
RSV: Respiratory Syncytial Virus
• No approved vaccine; high unmet medical need
• Responsible for a similar number of deaths as the flu in children up to 14, as well as in the elderly population
• Results in a high number of hospitalizations
MVA-BN RSV vaccine candidate
• Demonstrated strong immune response
• Blood and mucosal protection (key differentiator)
• Protection against both RSV subtypes (A&B) in preclinical models
COMMERCIAL VACCINES: RSV
MVA-BN RSV BOOSTS PRE-EXISTING RESPONSES
1 10 100 1000 10000 100000 Anti -RS V Anti bodi es in blo od (GMT) 1 10 100 1000 10000 100000 An ti -RSV anti bo dies in t he muco sa (GMT) Anti-RSV antibodies induced
by a previous RSV infection Anti-RSV antibodies boosted by a single vaccination with MVA-BN RSV
0 2
Weeks
0 2
Weeks
Anti-RSV antibodies measured by ELISA (Enzyme-linked immunosorbent assay)
• Animals that had previously been infected (and survived) an RSV infection were
vaccinated at week 0.
• Model mimics the situation of adults that have all been exposed to RSV
• Antibodies against RSV were boosted >7-fold & >75-fold in the blood and mucosa (lung) following a single vaccination with MVA-BN RSV
• Fully enrolled Phase 1, randomized, single-blind, monocenter, placebo controlled
• Healthy subjects, 18 – 65 years of age, N = 63
• Primary objective: Safety and reactogenicity of MVA-mBN294B (MVA-BN RSV vaccine)
• Secondary objective: RSV-specific (ELISA, PRNT, ELISPOT/ICS) and vaccinia-specific immune response to MVA-BN-RSV vaccine
MVA-BN RSV PHASE 1 INITIATED IN THE UNITED STATES
Groups N Age (years) Vaccine Dose per 0.5 ml
(nominal titers)
Schedule (Days)
1 18+3 18-49 MVA-BN RSV /placebo 1 x 107 TCID
50 0-28
2 18+3 18-49 MVA-BN RSV /placebo 1 x 108 TCID
50 0-28
3 18+3 50-65 MVA-BN RSV /placebo 1 x 108 TCID
50 0-28
Total 54+9 = 63
MVA-BN BRACHYURY
NOVEL IMMUNOTHERAPY CANDIDATE WITH BROAD POTENTIAL
Indications
• Chordoma (ultra-orphan disease)
• Triple negative breast cancer
• NSCLC
• Multiple solid tumors
Development Strategy
• NCI Phase 1 and Phase 2 studies
• NCI Phase 2 chemotherapy combination
study(s)
• NCI erlotinib combination study(s)
• NCI and BN immune checkpoint inhibitor
combinations
• Brachyury expression is highly correlated with metastatic disease, and multi-drug
resistance.
• Brachyury is not expressed in most normal tissue.
• Brachyury is responsible for epithelial to mesenchymal transition (EMT) which is a major driver of metastasis.
These findings show for the first time that advanced cancer patients can be safely immunized with an MVA-based vaccine targeting brachyury, and can develop
brachyury-specific T-cell immune responses.1
MVA-BN BRACHYURY: PHASE 1 DATA
•
38 patients with advanced cancer (N=25) or chordoma (N=13)
• Advanced cancers included Colorectal, Breast (ER+) NSCLCa (EGFR mutated),
Prostate, Pancreatic, Ovarian and Cholangiocarcinoma.
•
Dose escalation, safety and immunogenicity study
• No SAE’s associated with vaccine
• At DL2 and DL3, ~80% of the patients that demonstrated brachyury-specific T-cells
demonstrated responses in both CD4 and CD8 T-lymphocytes
Dose Level Dose and Schedule
1 (N=3) 1 site of injection at 2 x 108 IU given every 28 days for 3 doses. 2 (N=17) 2 sites of injection at 2 x 108 IU given every 28 days for 3 doses. 3 (N=18) 4 sites of injection at 2 x 108 IU given every 28 days for 3 doses.
FINANCIAL PERFORMANCE
• Revenues of more than DKK 1bn for the fourth consecutive year
• Break-even result for third consecutive year
• Cash preparedness doubled since 2013
-1000 100 200 300 400 500 600 700 800 900 1.000 1.100 1.200 1.300 2012 2013 2014 2015 Revenue EBIT
Revenue & EBIT (DKKm)
0 200 400 600 800 1.000 1.200 1.400 1.600 2012 2013 2014 2015
Cash preparedness (DKKm)
Cash preparednessmDKK mUSD
2015 guidance actual guidance actual
Revenue 1,000 1,021 146 149
EBIT 0 2 0 0
Cash preparedness at year-end 1,450 1,451 212 212
2015 RESULTS IN LINE WITH EXPECTATIONS
• Revenues of more than DKK 1bn
• 762 mDKK; deliveries of MVA-BN Filo to Janssen (112 mUSD)
• 181 mDKK; ongoing R&D contracts (27 mUSD)
• 78 mDKK; sale of IMVAMUNE to USA and rest of world (11 mUSD)
• Break-even result
2016E mDKK mUSD
Revenue 1,000 146
EBIT 0 0
Cash preparedness at year-end 1,300 190
FINANCIAL OUTLOOK
2016 guidance – another year with break-even expected
• More than 90% of revenues will be recognized in 2H 2016
• 750 mDKK from IMVAMUNE sales (110 mUSD)
• 250 mDKK from R&D contracts (37 mUSD)
• Total R&D costs of 580 mDKK (85 mUSD) of which 475 mDKK (70 mUSD) will be recognized in the P&L
• Ongoing evaluation of financing options based on market conditions, including
previously announced prospective registered public offering in the U.S. of the ADSs, the timing and terms of which have not yet been determined; year-end cash
preparedness does not include proceeds from any prospective share issuance
prostate cancer
• Interim analyses of Phase 3 study
• Phase 3 top-line data
• Initiate Phase 2 study in combination with
ipilimumab in collaboration with BMS
• Initiate NCI-sponsored Phase 2 study in
combination with ipilimumab and nivolumab
• Data from NCI-sponsored Phase 2 trials
• New NCI-sponsored combination trials
smallpox vaccine
• Finalize manufacturing activities to support a
U.S. EUA for freeze-dried IMVAMUNE
• Initiate manufacturing and storage of IMVAMUNE
bulk for the U.S. Government
• Additional Rest of World orders
• Complete enrollment of Phase 3 non-inferiority
study
projects
• MVA-BN RSV Phase 1 data
• MVA-BN RSV Phase 2 initiation
• MVA-BN Brachyury Phase 2 initiation
• CV-301 + checkpoint inhibitor Phase 2 initiation
in lung cancer
• CV-301 + checkpoint inhibitor Phase 2 initiation
in additional indications
• Initiate NIH-sponsored Phase 1 trial of
multivalent MVA-BN Filo
• Complete Phase 2 and Phase 3 studies of the
Ebola prime-boost vaccine regimen
• Potential expanded collaboration with Janssen
on additional infectious disease targets
ANTICIPATED SELECTED MILESTONES
2016/2017
PROSTVAC
IMVAMUNE
Promoters Co-Stimulatory Molecules (TRICOM) Antigens Recombinant Poxviruses Customized Immunogenicity Antigenic Complexity Low High Simple Complex + Vectors
LIVE VIRUS VACCINE PLATFORM
VALIDATED AND MODULAR APPROACH EMPLOYING POXVIRUSES
Wide Variety of Target Diseases Target Multiple Antigens for a Single Disease
0,1 1,0 10,0 100,0 1.000,0 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82
PROSTVAC - PATIENT CASE HISTORY (“FRANK”)
PUBLISHED 2013 CASE REPORT IN
CLINICAL GENITOURINARY CANCER
Age PSA
Trend before radical prostatectomy ( ) 5.8 months DT (doubling time)
Trend after radical prostatectomy. External beam radiation ( ) 9.6 months DT
Trend after first vaccine trial ( ) 28.6 months DT
Trend after second vaccine trial ( )
Gleason grade: 4 + 3 = 7 Radical Prostatectomy External Beam Radiation Vaccine Treatment Second Vaccine Treatment